Sample after >85% release [Dissolution / BCS / IVIVC]

posted by Obinoscopy  – USA, 2018-04-23 00:53 (1322 d 23:46 ago) – Posting: # 18721
Views: 9,239

» ƒ2 is generally not required if product(s!) release ≥85% in all three media.

You said Product(s) and not Products. So that means there are instances where f2 calculation can be shelved when only one product (either test or comparator product) releases >85% of API in 15 minutes?

Maybe it's better I present some hypothetical data to help me present my case:

If the 5, 10, 15, 20, 25, 30 and 45 mins dissolution values for the test product were 32%, 63%, 88%, 91%, 95%, 96% and 97% respectively. And that of the Comparator were 23%, 44%, 52%, 65%, 76%, 89% and 92% respectively.

Is f2 calculation required going by USFDA, EMA and WHO GLs? If it is, how's the calculation done?

» In the calculation of ƒ2 the devil is in the details. There are different restrictions on samples after 85% release:
  • FDA
    » Only one measurement included for test product.
  • EMA
    » Not more than one mean value for each formulation.
  • WHO
    » Maximum of one time-point of the reference product.
Hence, bad luck for the EMA. For the FDA and the WHO, it depends.

I really don't understand. Please can you explain further. I'm still a beginner in this field.

» BTW, what is an FFP?
Oops. Thought I wrote FPP. apologies for the typo.



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